Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study

Gansu Provincial Hospital

Status and phase: Unknown; Phase 4

Conditions: Dexmedetomidine; Ropivacaine; Lobectomy; Dexamethasone

Treatments: Drug: dexamethasone; dexmedetomidine; ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04763434

GanSu provincial hospital

Details and patient eligibility

About

The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB.

Full description

Design: A prospective, randomized, controlled study Setting: Single-center university hospital. Participants: The study included 90 patients undergoing lobectomy under general anesthesia.

Interventions: The patients were allocated randomly into the following 3 groups: 20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone (RS group) or 1 µg/kg dexmedetomidine (RM group), or with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group). Ultrasound-guided TPVB was performed at 4 points-T4-5, T5-6, T6-7, and T7-8 of the surgical side; 5 mL of solution were injected at each point. Postoperatively, the PCIA was used as part of multimodal analgesia, and all patients recieve .

Enrollment: 90 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

ASA physical status I-II grade Undergoing elective lobectomy under general anesthesia. Participants aged from 16-65 years old.

Exclusion criteria

Refusal for TPVB Inability to obtain informed consent Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2 Pregnancy Infections at the site of injection for the TPVB Allergy to dexamethasone; dexmedetomidine; ropivacaine Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

RS group

Active Comparator group

Description:

20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone

Treatment:

Drug: dexamethasone; dexmedetomidine; ropivacaine

RM group

Active Comparator group

Description:

20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine

Treatment:

Drug: dexamethasone; dexmedetomidine; ropivacaine

RSM group

Experimental group

Description:

20 ml mixture of 37.5 mg ropivacaine with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group)

Treatment:

Drug: dexamethasone; dexmedetomidine; ropivacaine